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Life cycle of medical devices

Life cycle of medical devices

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Life cycle of medical devices

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  1. Life cycle of medical devices Gerald Verollet World Health Organization 3rd SIGN Meeting - New Delhi

  2. The risk/benefit nature of medical devices The goal is to maximize benefit and to minimize risk

  3. Definition of medical device • Article, instrument, apparatus or machine • for • Diagnosis, treatment or prevention of disease • or for • detecting, measuring, restoring, correcting or modifying

  4. Risk management in medical device • Degree of risk • Risk assessment of devices • Risk management

  5. PRODUCT Pre-market review USE Post-market surveillance Critical factors for medical device safety and effectiveness • Presentation of product to user

  6. The different phases of medical device From Conception to disposal

  7. Life Cycle of a Medical Device Conception and Design Manufacture Packaging Labelling Advertising Sale Use Disposal • 1 2 3 4 5 6 7

  8. Life Cycle of a Medical Device Conception and Design Manufacture Packaging Labelling Advertising Sale Use Disposal Pre-market Post-market On-market

  9. Life Cycle of a Medical Device Conception and Design Manufacture Packaging Labelling Advertising Sale Use Disposal Pre-Market

  10. Life Cycle of a Medical Device Conceptionand Design Manufacture Packaging Labelling Advertising Sale Use Disposal On-Market

  11. Life Cycle of a Medical Device Conception and Design Manufacture Packaging Labelling Advertising Sale Use Disposal Post-Market

  12. The role of each participant/stakeholder Manufacturer Importer/ Vendor Government User Public

  13. Life Cycle of a Medical Device Conception and Design Manufacture Packaging Labelling Advertising Sale Use Disposal MANUFACTURER USER VENDOR

  14. The safety and effectiveness of medical devices demands co-operation among stakeholders • The Manufacturer • The vendor • The users • The Public • The Governnent

  15. The nature of medical device safety • A risk management issue • tied with device effectiveness/performance • Throughout the life cycle of the device

  16. Communication Between the Actors Manufacturer Importer/ Vendor Government • Shared • Responsibility User Public